Overlapping Resilient Member Structures in Nasal Dilator Devices

ABSTRACT

A nasal dilator is constructed as a single body truss having a resilient member structure comprising a plurality of overlaid, island-placed, or overlapping resilient members. Methods of mass producing dilator devices, individual resilient members, and overlapped, overlaid, and island-placed resilient member structures are also disclosed.

RELATED APPLICATIONS

Not applicable.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, andparticularly to medical devices composed of at least two overlapping oroverlaid components, including those medical devices having at least onecomponent centrally registered, or island-placed, with at least oneother component. The present invention further relates generally tomethods of manufacturing, or converting, elongated sheets or rolls ofthin flexible materials such as papers, thermoplastic films, foils,medical grade tapes, synthetic fabrics and the like into medical devicesor components thereof.

The present invention relates more specifically to apparatus for andmethods of dilating external tissue, and to methods of manufacturingtissue dilator devices for use in humans and equine athletes. Asdisclosed and taught in the preferred embodiments, the tissue dilatordevices and methods of manufacturing tissue dilators or componentsthereof are particularly suitable for, and are directed primarily to,external nasal dilators used in supporting, stabilizing and dilatingouter wall tissues of the nasal airway passages of the human nose. TheUnited States Food and Drug Administration classifies the external nasaldilator as a Class I Medical Device.

BACKGROUND OF THE INVENTION

A segment of the human population has some malformation of the nasalpassages that interferes with breathing, including deviated septa orinflammation due to infection or allergic reactions. Part of theinterior nasal passage wall may draw in during inhalation tosubstantially block the flow of air. Blockage of the nasal passages as aresult of malformation, or nasal congestion symptoms of the common coldor seasonal allergies are particularly uncomfortable at night, and canlead to sleep disturbances, irregularities and general discomfort.

In use the external nasal dilator is flexed across the bridge of thenose, extending over and engaging the nasal passage outer wall tissueson each side of the bridge, and held thereto by adhesive. A resilientmember (synonymously referred to in the art as a spring, spring member,resilient band, resilient member band, or spring band) extends along thelength of the device, embedded within or affixed thereto. When flexedacross the bridge of the nose, the resilient member, having resiliencyor resilient properties, exerts spring biasing forces extending from themiddle of the dilator to its opposite end regions, which urges the nasalouter wall tissues outward, providing dilation and/or stabilizationthereto. Stabilized or dilated tissue decreases airflow resistancewithin the nasal passages, allowing for a corresponding increase innasal airflow. Increased nasal airflow may have a beneficial effect onnasal congestion, nasal snoring and obstructive sleep apnea.

A portion of the external nasal dilator art is suitable for massproduction and commercialization in the consumer market, includingdevices disclosed in U.S. Pat. Nos. D379513, 6,453,901, D429332,D430295, D432652, D434146, D437641 and U.S. patent application Ser. Nos.12/024,763, 12/106,289, 12/402,214, 12/964,746 and 29/380,763, theentire disclosures of which are incorporated by reference herein. Nasaldilators that have heretofore been widely available to consumers througha retail product category referred to generically as nasal stripsinclude devices disclosed in U.S. Pat. Nos. D379513, 5,533,503,5,546,929, RE35408, and 7,114,495.

The preferred thermoplastic material from which external nasal dilatorresilient members are fabricated carries a significantly greater costper unit of measure than other materials typically found in nasaldilator construction. Accordingly, simple resilient member structures,such as one or two rectangular resilient bands having a single thicknessprevail in dilator devices that have been successfully commercialized.These resilient members are easily mass produced, extending the entirelength of the dilator device so as to be severed at the dilator deviceends in a continuous die-cutting process.

A single rectangular resilient member bisected lengthwise into two orthree narrower, closely parallel members, each having the samethickness, length and width, is disclosed in the art. A single resilientmember having divergent end portions, or multiple resilient memberstructures where one or more individual members have divergent endportions, are more recent in the art. In each case, the multipleresilient members are positioned adjacent each other and slightly spacedapart, as seen, for example, in U.S. Pat. No. 6,453,901 and U.S. patentapplication Ser. Nos. 12/024,763 and 12/106,289.

A dynamic relationship exists between dilator design and its efficacy,including resiliency, comfort and useful duration (i.e., the amount oftime the device will remain effectively adhered to the skin). To beeffective for a majority of users, a nasal dilator must generate fromabout 15 grams to about 35 grams of resiliency, or spring biasing force.Less than 15 grams may not provide enough stabilization or dilation,while greater than 35 grams would be uncomfortable for most users. Theamount of spring biasing force is determined by the type of resilientmember material used, its peripheral configuration, its overall widthand length, and its thickness.

Nasal dilator resiliency creates primarily peel forces at the device endregions together with some tensile forces that work to disengage thedevice from the skin. External nasal dilators having design attributesthat transform or redirect at least some disengaging peel and tensileforces into shear forces are disclosed in U.S. Pat. Nos. 5,533,503,6,453,901 (FIGS. 10-11), and in U.S. patent application Ser. Nos.12/106,289, 12/964,746 and 29/380,763. Shear forces are more easilywithstood by adhesives typically used to engage nasal dilators to theskin surface of the nose. Other external nasal dilators, such as thosedisclosed in U.S. Pat. Nos. 6,543,901, 5,546,929 and RE35408 and U.S.patent application Ser. No. 12/402,214, overcome disengaging peel forcesusing an island-placed resilient member centrally registered within thedevice's peripheral edges. Skin-engaging material extends continuouslyoutward beyond the peripheral edges of the resilient member,particularly from the opposite ends thereof, to overcome disengagingpeel and tensile forces thereat. Island-placed resilient memberstructures are traditionally more costly to fabricate and have been lesscommon in mass-produced dilator devices.

U.S. Pat. No. 6,375,667 (Ruch) discloses a nasal dilator having firstand second resilient bands secured to first and second end regions of aflexible strip, plus a third resilient band interconnecting the firstand second bands. The ends of the third resilient band overlap theinward ends of the first and second resilient bands, respectively, suchthat the three bands extend in a longitudinal line successively from endto end. U.S. Pat. No. 6,470,883 (Beaudry) discloses a nasal dilatorhaving two stacked rectangular spring laminates (22, 24) that form aleaf spring (20). The upper laminate has a shorter length, but appearsto have the same width and thickness as the lower laminate.

There is a continuing need in the art to address nasal dilatordisengaging or delaminating peel forces, the dynamic relationshipbetween adhesive engagement and spring biasing forces, and toeconomically manufacture on a mass scale nasal strip devices havingcomplex resilient member structures of improved efficacy, durationallongevity, and comfort. Furthermore, the nasal strip consumer productcategory has heretofore been dominated by a single brand, creating apent up demand for innovation, competition, variety and complexity innasal strip products.

SUMMARY OF THE INVENTION

Dilator devices of the present invention comprise a functional element,an engagement element, and a directional element in a laminate ofvertically stacked layers formed as a unitary, single body truss. Thetruss comprises first and second end regions adapted to engage outerwall tissues of first and second nasal passages, respectively, and anintermediate region adapted to traverse a portion of a nose locatedbetween the first and second nasal passages. The truss is capable ofresilient deformation; when flexed and released it returns to asubstantially planar or pre-flexed state. In use the dilator stabilizesnasal outer wall tissues to prevent tissues thereof from drawing inwardduring breathing, and may further expand, or dilate, the nasal outerwalls. The truss is configured to be comfortable on the skin surfacesengaged and to be easily removed with little or no stress thereto.

Embodiments of the present invention are directed to nasal dilatorsadapted for use on the human nose. With appropriate adjustments to size,resiliency, and engagement means, the dilator devices depicted hereinmay be adapted for use on equine athletes.

Dilator layers are formed in whole or part from elongated material webscombined with elongated material strands. Dilator layers are preferablysecured to one another by an adhesive substance disposed on at leastportions of at least one flat surface side of at least one layer. Theresulting laminate of vertically stacked layers forms a unitary, orsingle body, truss. Each layer includes one or more members. A membermay further include one or more components, as described herein. Each ofthe engagement, functional, and directional elements is defined by atleast a portion of at least one layer of the dilator.

The functional element comprises a resilient member structure havingresilient properties that generate spring biasing force or resiliency.(The terms spring biasing, spring biasing force, spring force,resiliency, spring constant, etc. as used herein are generallysynonymous.) The engagement element affixes, adheres, or engages thedilator to the nasal outer wall tissues. The engagement element, byitself, does not provide nasal dilation, although depending on thematerial used and its specific construction, could provide tissuestabilization. A simple oblong resilient member configuration, astypically found in dilator devices, generally will not by itself remainadhered to the nasal outer wall tissues for a suitable length of time.Accordingly, dilator devices of the present invention preferably includean engagement element in the form of at least one dedicated dilatorlayer that defines at least a substantial portion of the body of thetruss and its peripheral outline. Alternatively, resilient memberstructures of the present invention may form the truss in its entirety.

The directional element modifies, directs, affects or alters springbiasing properties generated by the functional element of the dilator soas to enhance device efficacy, engagement, useful duration, comfort orease of use. The directional element includes one or more designfeatures that: spread spring biasing forces to a greater lateral extentof the dilator; increase or decrease localized spring biasing forces;mitigate or transform delaminating peel and tensile forces, at least inpart, from primarily peel forces to primarily shear forces; directspring biasing forces to discrete contact points on each side of thebridge of the nose; create lessening of or gradiently reduce springbiasing forces at the device end regions.

Nasal dilator devices of the present invention include a resilientmember structure comprising at least two resilient members, and oftenthree or more resilient members, arranged in an overlapping or overlaidspatial relationship relative to each other. Where one resilient memberoverlays another, an overlap surface area may include the entirety of aflat surface of one member. Where resilient members overlap, an overlapsurface area typically extends across the overlapping resilient members'mid-sections, corresponding to at least a portion of the intermediateregion of the truss. Overlaid resilient members are typically parallelto each other. Overlapping resilient members may also be parallel toeach other, or their long edges may intersect or cross at an obliqueangle. Overlaid resilient members may have progressively less length orwidth: a lateral stepped reduction in width (and thus thickness)extending perpendicular from the longitudinal centerline of the truss,or a longitudinal stepped reduction in length (and thus thickness)extending parallel to the longitudinal centerline of the truss, or acombination of both.

Resilient member structures of the present invention also includes atleast one non-overlap surface area, having a thickness, and at least oneoverlap surface area, having a thickness greater than any non-overlapsurface area. Non-overlap surface areas are generally a first thickness.(An exception, for example, is if two overlapping resilient members areeach a different thickness, and cross in the form of an X so as to formfour non-overlap areas, two non-overlap areas will have a greaterthickness and two non-overlap areas will have a lesser thickness.)Otherwise, one resilient member overlapping or overlaid onto anothercreates at least one overlap surface area having a second thicknessequal to the combined thickness of the two members. A thirdoverlapping/overlaid member creates at least one overlap area having athird thickness, and so on. The relationship between overlap andnon-overlap surface areas is dynamic, determined by length, width,peripheral configuration, and the spatial relationship between theresilient members.

Resilient member structures of the present invention are configured to:create areas of greater and lesser thickness and thus correspondingresiliency; generate greater spring biasing forces along at least oneoverlap surface area compared to one or more non-overlap surface areas;gradiently reduce spring biasing forces across the width and/or alongthe length of the truss; form spring finger components of lesserthickness extending to discrete engagement contact points having lesserspring biasing force thereat; and create the effect of an additionalisland-placed resilient member without having to fabricate and positionone. Embodiments of the present invention illustrate complementaryoverlapping and overlaid resilient member structures having similardimensions and resilient properties; the former including at least oneresilient member overlapping another, the latter including at least oneresilient member overlaid and centrally registered with, orisland-placed onto, another.

Individual resilient members of the present invention may be configuredto any viable peripheral shape, size or thickness, and are configured tobe fabricated in a continuous process. The continuous process formsresilient members end to end, spaced apart, or nested along common diecut lines so as to form complex structures with the same efficiency andeconomy as traditional or more simply constructed resilient members orstructures. Continuous slits form elongated strands from one or morewebs of resilient material; select strands are separated from the weband combined, or overlaid, with each other, then combined with at leastone additional web and/or material strand to form a fabrication laminatefrom which finished dilator devices are die cut. The process may alsoform individual resilient members spaced apart and divided into stripsthat may be combined so as to island-place, or centrally register, thespaced apart members to each other. The process may also be applicableto those medical devices where overlapping or island-placed componentsare required.

The individual resilient members within a resilient member structure maybe vertically separated by one or more of an intermediate material layerinterposed therebetween so as to separate one or more resilient membersinto two or more resilient layers. The intermediate layer may comprisean adhesive substance or a flexible material, or both. The intermediatelayer may further contribute to the engagement element of the dilator,particularly where the resilient member structure forms the body of thetruss in its entirety, or intermediate layer may define at least aportion of the truss peripheral outline.

The present invention builds upon the prior art and discloses new,useful, and non-obvious resilient member structures comprisingoverlapped and overlaid resilient members, including methods ofeconomically and efficiently mass producing said structures andincorporating them into dilator devices.

It is the principal objective of the present invention to provide novelnasal dilator devices having complex overlapping, overlaid andisland-placed resilient member structures. A further objective of thepresent invention is to provide novel methods of fabricating saidstructures, and converting elongated flexible material webs intofinished medical devices or components thereof, including means forcentrally registering parts or components to each other.

The present invention is not limited to the illustrated or describedembodiments as these are intended to assist the reader in understandingthe subject matter of the invention. The preferred embodiments areexamples of forms of the invention comprehended by that which is taught,enabled, described, illustrated and claimed herein. All structures andmethods that embody similar functionality are intended to be coveredhereby. The manufacturing methods depicted, taught, enabled anddisclosed herein, while particularly suitable for dilator devices, maybe applicable to other medical devices. The nasal dilators depicted,taught, enabled and disclosed herein represent families of new, usefuland non-obvious devices having a variety of alternative embodiments.Dilator elements, layers, members, components, materials, or regions maybe of differing size, area, thickness, length, width or shape than thatillustrated or described while still remaining within the purview andscope of the present invention. The preferred embodiments include,without limitation, the following numbered discrete forms of theinvention, as more fully described herein.

Some embodiments of the present invention are arranged in groups so asto illustrate similarly configured resilient member structures or toillustrate manufacturing steps. Each group introduces a new orsubsequent feature, design element, manufacturing technique, orvariation thereof. Accordingly, later embodiments may refer to, or crossreference, previous embodiments. It will be apparent to one of ordinaryskill in the art that device or component configuration, techniques,methods, processes, etc., may be applied, interchanged or combined fromone embodiment or group thereof to another. Elongated material webs aregenerally shown in the drawings as only wide enough to illustrate thesubject at hand. In practice, said widths may be greater, and in somecases lesser. The longitudinal extents of material webs, where shown,are fragmentary.

For descriptive clarity, certain terms are used consistently in thespecification and claims: Vertical refers to a direction parallel tothickness, such as the thickness of a finished device, a material web,material layers, or a material laminate. Horizontal refers to length orlongitudinal extent, such as that of a finished device, or a directionparallel thereto. Lateral refers to width, such as that of a finisheddevice or a material web, and to a direction parallel to the crossdirection (XD) of a material web. Longitudinal refers to length, such asthat of a finished device, or the length or machine direction (MD) of amaterial web, or a direction perpendicular to width or lateral extent. Alongitudinal centerline is consistent with the long axis of a finisheddevice or material web, bisecting its width midway between the longedges. A lateral centerline bisects the long edges of a finished deviceor material web midway along its length, and is perpendicular to thelongitudinal centerline. An object or objects referred to as adjacent orconsecutive another generally means laterally, consistent with the widthof a finished device or a material web. Objects referred to assuccessive are generally oriented lengthwise, end to end, parallel tothe machine direction (MD) of a material web. The terms upper and lowermay be used, particularly in plan views, to refer to object orientationon a drawing sheet.

Broken lines and dashed lines are used in the drawings to aid indescribing relationships or circumstances with regard to objects:

-   -   A broken line including a dash followed by three short spaces        with two short dashes therebetween indicates separation for        illustrative purposes, such as in an exploded view, or to        indicate an object or objects removed or separated from one or        more other objects as the result of a process or method.    -   A dashed line of successive short dashes with short spaces        therebetween may be used to illustrate an object, such as one        underneath another; or for clarity, to show location, such as        the space an object or structure will occupy, would occupy, or        did occupy; or for illustrative purposes, to represent an        object, structure or layer(s) as ‘invisible’ so that other        objects more pertinent to the discussion at hand may be        highlighted or more clearly seen.    -   A broken line including a long dash followed by a short space, a        short dash and another short space is used to call out a        centerline or an angle, or to indicate alignment; when        accompanied by a bracket, to call out a section, segment or        portion of an object or a group of objects; to illustrate a        spatial relationship between one or more objects or groups of        objects, or to create separation between objects for the purpose        of illustrative clarity.

In the drawings accompanying this disclosure, like objects are generallyreferred to with common reference numerals or characters, except wherevariations of otherwise like objects must be distinguished from oneanother. Where there is a plurality of like objects in a single drawingfigure corresponding to the same reference numeral or character, only aportion of said like objects may be identified. After initialdescription in the text, some reference characters may be placed in asubsequent drawing(s) in anticipation of a need to call repeatedattention to the referenced object. In describing manufacturing methods,Machine Direction is indicated in the drawings by the letters ‘MD’adjacent a directional arrow: a single arrowhead indicates preferreddirection; a double arrowhead indicates flow may be in either direction.Drawings are not rendered to scale, and where shown, the thickness ofobjects is generally exaggerated for illustrative clarity.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 a is a perspective view showing a human nose, depicted in brokenlines, with the attachment thereon of a first form of nasal dilator inaccordance with the present invention.

FIG. 1 b is an exploded perspective view of the nasal dilator of FIG. 1a.

FIG. 1 c is a perspective view of the nasal dilator of FIG. 1 b.

FIG. 2 a shows two perspective views of resilient member structures seenin FIG. 1 comprising two and three resilient members, respectively.

FIG. 2 b shows two sectional views comprising two and three resilientmembers, respectively, on an enlarged scale, taken along the lines 2-2in FIG. 2 a.

FIG. 2 c is a sectional view of the resilient member structure of FIG. 2b comprising three resilient members and further including intermediatematerial layers.

FIG. 3 is a cross sectional view of adjacent parallel resilient membersshown for comparison to FIG. 2 b.

FIG. 4 a is an exploded perspective view of a second form of nasaldilator in accordance with the present invention.

FIG. 4 b is a fragmentary plan view on an enlarged scale of the endregion of the second form of nasal dilator in accordance with thepresent invention.

FIG. 4 c is a plan view of the nasal dilator of FIG. 4 a.

FIG. 5 is a plan view of the individual resilient members comprising theresilient member structure of the nasal dilator of FIG. 4.

FIGS. 6 a and 6 d are plan views illustrating initial steps of a firstform of manufacturing method in accordance with the present invention bywhich to fabricate individual resilient members comprising resilientmember structures substantially as illustrated in FIG. 4.

FIGS. 6 b, 6 c and 6 e perspective views illustrating subsequent stepsof the first manufacturing method.

FIG. 7 a is a plan view of a third form of nasal dilator in accordancewith the present invention.

FIG. 7 b is a plan view of the individual resilient members comprisingthe resilient member structure of the nasal dilator of FIG. 7 a.

FIG. 7 c is an exploded perspective view of the nasal dilator of FIG. 7a.

FIG. 7 d is a perspective view highlighting the resilient memberstructure shown in FIG. 7 c.

FIG. 8 is a plan view of a second form of manufacturing method by whichto fabricate the individual resilient members comprising the resilientmember structure of the nasal dilator of FIG. 7.

FIG. 9 a is a plan view of a fourth form of nasal dilator in accordancewith the present invention.

FIG. 9 b is an exploded perspective view of the nasal dilator of FIG. 9a.

FIG. 9 c is a side elevation showing the attachment of the nasal dilatorof FIG. 9 a to the nose of a wearer depicted in broken lines.

FIGS. 10 a and 10 b are exploded perspective views illustrating analternative configuration of the fourth form of nasal dilator.

FIG. 10 c is a plan view of the nasal dilators shown in FIGS. 10 a and10 b.

FIGS. 11 a-11 c are plan views highlighting the resilient memberstructures of the nasal dilators shown in FIGS. 9 and 10.

FIGS. 12 a and 12 b are plan views of a third form of manufacturingmethod in accordance with the present invention by which to fabricateresilient member structures substantially as illustrated in FIGS. 9 and10.

FIGS. 13 a-13 c are exploded perspective views highlighting theresilient member structures of a fifth form of nasal dilator inaccordance with the present invention.

FIG. 14 a is a plan view illustrating the initial steps of a fourth formof manufacturing method in accordance with the present invention bywhich to fabricate member structures substantially as seen in FIG. 13.

FIGS. 14 b-14 d are exploded perspective views illustrating subsequentsteps of the third manufacturing method.

FIGS. 15 a and 15 b are plan views of a sixth form of nasal dilator inaccordance with the present invention.

FIG. 16 is an exploded perspective view highlighting the resilientmember structure of a seventh form of nasal dilator in accordance withthe present invention.

FIGS. 17 a and 17 b are plan views of a eighth form of nasal dilator inaccordance with the present invention.

FIG. 17 c is a plan view highlighting the individual resilient memberscomprising the resilient member structure illustrated in FIG. 17 b.

FIG. 17 d is a side elevation showing the attachment of the nasaldilator of FIG. 17 a to the nose of a wearer depicted in broken lines.

FIG. 18 is a perspective view highlighting the resilient memberstructure of a ninth form of nasal dilator in accordance with thepresent invention.

FIGS. 19 a and 19 b are plan views of a fifth form of manufacturingmethod in accordance with the present invention by which to fabricateindividual resilient members comprising resilient member structuresparticularly illustrated in FIG. 18.

FIG. 19 c is an exploded perspective view of the fifth manufacturingmethod.

FIGS. 20 a, 21 a, and 22 a are plan views of three variations of a tenthform of nasal dilator in accordance with the present invention.

FIGS. 20 b, 21 b and 22 b are plan views of the individual resilientmembers comprising the resilient member structures illustrated in FIGS.20 a, 21 a, and 22 a, respectively.

FIGS. 20 c, 21 c, and 22 c are plan views highlighting the resilientmember structures of the dilators illustrated in FIGS. 20 a, 21 a, and22 a, respectively.

FIGS. 20 d, 21 d and 22 d are exploded perspective views highlightingthe resilient member structures of the nasal dilators illustrated inFIGS. 20 a, 21 a, and 22 a, respectively.

FIGS. 23 a, 24 a, and 25 a are plan views of three variations of aneleventh form of nasal dilator in accordance with the present invention.

FIGS. 23 b, 24 b, and 25 b are plan views highlighting the resilientmember structures of the nasal dilators illustrated in FIGS. 23 a, 24 a,and 25 a, respectively.

FIGS. 23 c, 24 c and 25 c are perspective views highlighting theresilient member structures of the nasal dilators illustrated in FIGS.23 a, 24 a, and 25 a, respectively.

FIGS. 26 a, 26 b, 26 c and 26 d are exploded perspective views of atwelfth form of nasal dilator in accordance with the present invention,highlighting the resilient member structures thereof.

FIGS. 27 a and 27 b are exploded perspective views of a thirteenth formof nasal dilator in accordance with the present invention, highlightingthe resilient member structures thereof.

FIGS. 28 a, and 29 a are plan views of two variations of a fourteenthform of nasal dilator in accordance with the present invention.

FIGS. 28 b and 29 b are plan views highlighting the resilient memberstructures of the nasal dilators illustrated in FIGS. 28 a and 29 a,respectively.

FIGS. 28 c and 29 c are perspective views highlighting the resilientmember structures of the nasal dilators illustrated in FIGS. 28 a and 29a, respectively.

FIG. 30 a is a plan view of a fifteenth form of nasal dilator inaccordance with the present invention.

FIG. 30 b is an exploded perspective view highlighting the resilientmember structure of the nasal dilator of FIG. 30 a.

FIG. 31 a is a plan view of a variation of the nasal dilator of FIG. 30.

FIG. 31 b is a perspective view highlighting the resilient memberstructure of the nasal dilator of FIG. 31 a.

FIG. 31 c is a side elevation showing the attachment of the nasaldilator of FIG. 31 a to the nose of a wearer depicted in broken lines.

FIGS. 32 a and 32 b are perspective views highlighting the resilientmember structure of a variation of the nasal dilator of FIG. 30.

FIG. 33 a is a plan view of a sixteenth form of nasal dilator inaccordance with the present invention.

FIG. 33 b is an exploded perspective view highlighting the resilientmember structure of the nasal dilator of FIG. 33 a.

FIG. 34 a is a plan view of a variation of the nasal dilator of FIG. 33.

FIG. 34 b is a perspective view highlighting the resilient memberstructure of the nasal dilator of FIG. 34 a.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of a nasal dilator, 10, in accordance with the presentinvention is illustrated in FIG. 1. Shown in use, dilator 10 is engagedto a human nose, represented by dashed lines. FIG. 1 a illustrates ahorizontal protrusion, 12, which separates slightly from the skinthereat as a result of the dilator end region structure, a directionalelement that shifts a portion of spring biasing forces from primarilypeel forces to primarily shear forces, so as to improve engagement tothe nasal outer wall tissues.

As seen more clearly in FIGS. 1 b and 4 a, dilator 10 comprises alaminate of vertically stacked layers aligned along a verticalcenterline, v, and a longitudinal centerline, a, indicated by brokenlines. Dilator layers include: a base layer comprising at least one basemember, 14; a resilient member structure, 22, comprising at least onelayer and a plurality of resilient members, 22 a, 22 b, and 22 c; acover layer comprising at least one cover member, 18; and one or more ofan optional intermediate layer, 16, illustrated by dashed lines, whichmay be positioned between any two of the aforementioned layers ormembers. Any layer may overlap or overlay any other layer in whole or inpart. The peripheral dimensions of dilator 10 may be defined, in wholeor part, by resilient member structure 22, or by any dilator layer orportion thereof, or by any combination of layers.

A protective layer of release paper, 15, removably covers exposedadhesive from any other layer preliminary to using the dilator. Theshape and dimensions of release paper 15 may correspond to the peripheryof dilator 10 or may exceed the periphery of one or more dilators 10.Release paper 15 may be bisected into two parts, which may overlap orabut, so as to facilitate removal from the dilator prior to use.

The base and cover layers of dilator 10 may be fabricated concurrentlyso as to have the same peripheral shape. Alternatively, the base andresilient layers may be fabricated concurrently to the same peripheralshape or the base layer may have a greater surface than the resilientlayer(s) but lesser than the cover layer. The base and cover layers maybe interchanged, the base and/or cover layers may be eliminated in wholeor in part, or the cover layer may be interposed between the resilientlayer and the skin surfaces engaged by the dilator. The cover layer maybe divided into two parts, one each substantially defining each endregion of the dilator.

Where the base layer has a significantly lesser surface area than thecover layer, adhesive on the skin-engaging side of the base layer may beoptionally eliminated in whole or part. With or without adhesive, thebase layer may also serve as a compressible buffer between the deviceand the skin, as has been historically common in medical devices thatremain in contact with the skin for any length of time.

Dilators of the present invention generally include dedicated functionaland engagement elements: the resilient member structure providing theformer and the base layer and/or cover layer, and optionally theintermediate layer, providing the latter. Alternatively, resilientmember structures of the present invention are configured, or otherwisemay be configured, to form the truss in its entirety. Specifically,structures having a directional element that significantly reducesand/or laterally spreads spring biasing forces across the lateral extentof the truss, particularly at the end regions thereof, and resilientmember structures comprising multiple engagement contact points aregenerally suitable or adaptable for use without the addition of aseparate, dedicated engagement element. Of necessity, however, thesestructures preferably include an adhesive substance disposed on at leasta portion of the tissue-engaging surface(s) thereof.

Dilator layers may be secured to each other by any suitable means suchas stitching or fastening, heat or pressure bonding, ultrasonic welding,or the like, but are preferably laminated by an adhesive substancedisposed on at least one flat surface side of at least one layer. Thismay be in addition to or in lieu of intermediate layer 16, which maycomprise an adhesive substance, a carrier material, or a carriermaterial with an adhesive substance disposed on one or both flat surfacesides whereby to bond two dilator layers together.

The preferred material for the dilator base and cover layers is from agroup of widely available flexible nonwoven synthetic fabrics that arebreathable and comfortable on the skin. Any suitable fabric orthermoplastic film, or various clear films, including high MoistureVapor Transmission Rate (MVTR) polyurethane film, are suitable. Apressure sensitive adhesive, preferably biocompatible with externalhuman tissue, may be disposed on at least one flat surface side of thematerial. A protective, removable, release liner covers the adhesive.The preferred materials are typically available in rolls wound in themachine direction (MD), or warp, of the material, which is perpendicularto the cross direction (XD), or fill, thereof.

The preferred material for the dilator resilient members is a widelyavailable biaxially oriented polyester resin (PET), a thermoplastic filmhaving suitable spring biasing properties across both its warp and fill.The material may have a pressure sensitive adhesive disposed on one orboth flat surfaces covered by a removable protective release liner. PETmay be laminated to the preferred base layer material, from the adhesiveside of the former to the non-adhesive side of the latter, so that atleast one resilient member and the base layer of dilator 10 may be diecut concurrently.

The functional element of dilator 10 is configured to provide springbiasing force within a suitable, or functional, range as describedhereinbefore. The functional element of the present invention comprisesa plurality of resilient members positioned, at least in part, in anoverlapping or overlaid relationship in one or more resilient layers.Spring biasing force and its directional application is determined bythe dimensional configuration of each resilient member and the combinedresilient members, or resilient member structure, including overlap andnon-overlap surface areas. A resilient member may have an adhesivesubstance disposed on at least a portion of at least one of two oppositeflat surface sides for engaging or laminating it to other layers,members or components of dilator 10, or for adhering directly to thenasal outer wall tissues.

FIG. 1 c illustrates that the layers of dilator 10 form a unitary, orsingle body, truss, 30, having a length, or longitudinal extent, c,indicated by broken lines and a bracket. Truss 30 has contiguous regionsindicated generally by broken lines and brackets, including a first endregion, 32, a second end region, 34, and an intermediate region, 36,which joins first end region 32 to second end region 34.

The truss end regions provide the primary surface area engagement to thenasal outer wall tissues on each side of the bridge of the nose. Thewidth of intermediate region 36 is preferably narrower than the width ofend regions 32 and 34. Portions of any layer may define a region of thetruss or a portion thereof. The layers, members or components of dilator10 may extend from one region to another. In the preferred embodimentsend regions 32 and 34 are shown as identical in peripheral configurationand in size and shape. That is, they are the mirror images of eachother. However, it will be apparent to one of ordinary skill in the artthat they may be configured asymmetric or non-identical in size, shapeor scale.

FIGS. 1 and 2 illustrate an overlaid resilient member structure of thepresent invention in its simplest form. A flat surface side of at leastone resilient member is overlaid onto at least a portion of a flatsurface side of at least one other resilient member. The resilientmembers are substantially parallel to each other, and include a firstresilient member, 22 a, a second resilient member, 22 b, and a thirdresilient member, 22 c. A resilient member has opposite terminal ends,23, which may extend to, align with, or conform to a portion of each endedge of dilator 10, or extend short of either end edge. The resilientmembers may be stacked in any order, but are preferably stacked fromwider to narrower. One or more resilient members may be optionallypositioned as the uppermost, or visible, layer when the dilator is seenin a top-down plan view or engaged to the nose. The resilient membersare generally of similar shape, but may be of different size, thickness,width or length.

FIG. 2 b shows overlaid resilient members 22 a and 22 b forming anoverlap surface area, 20, as well as non-overlap surface areas, 19, asindicated by broken lines and brackets. Resilient member 22 c in turnoverlays resilient member 22 b, which creates another overlap surfacearea. (Note: whether resilient members overlay or overlap, the area ofresulting combined thickness is always referred to by the term “overlaparea” or “overlap surface area”.) The resilient layer structure thus hasat least one non-overlap surface area having a first thickness; overlaidresilient member 22 b creates at least one overlap surface area of asecond thickness, and overlaid resilient member 22 c creates at leastone overlap surface area of a third thickness. Directional arrowsillustrate a stepped reduction from greater to lesser thickness of theresilient member structure, and thus a corresponding stepped reductionin resiliency thereof, extending laterally from longitudinal centerlinea and vertical centerline v to respective outer long edges of resilientmember 22 a. The number of steps corresponds to the number of overlaidresilient members.

The thickness of respective overlap surface areas 20 shown in FIG. 2 bis equal to the combined thickness of the overlaid resilient members.The same stepped reduction in thickness may be seen in multiple parallelresilient member bands of varied thickness, spaced apart slightly, asshown for comparison by cross section in FIG. 3: the outermost bandshave a thickness corresponding to non-overlap areas; the band(s) inboardthereof have greater thickness corresponding to overlap surface areas.The adjacent resilient members seen in FIG. 3 would have slightlygreater axial, torsional flexibility in a dilator device than the fewerresilient members overlaid as seen in FIG. 2. However, the resilientmember structure of FIG. 2 may have a lower manufacturing cost.

FIG. 2 c shows that resilient members may be vertically separated byintermediate layer 16 interposed therebetween, dividing the resilientmember structure into two or more resilient layers. Intermediate layer16 preferably comprises a very thin, inexpensive flexible material, suchas a synthetic fabric or thermoplastic film, having an adhesivesubstance disposed on at least one flat surface side. Alternatively,intermediate layer 16 may comprises an unsupported transfer adhesive.Depending on the material type, intermediate layer 16 may be used as amatter of structural integrity, manufacturing efficiency or expediency(see FIG. 19), or to aid alignment of dilator layers. It may also beused as the engagement element of the dilator, in whole or part. Theperiphery or width and length of intermediate layer 16 may be lesser orgreater than the individual resilient members, or other dilator layers,separated thereby.

As noted, the overlaid resilient member structure shown in FIGS. 1 and 2is a simple form thereof, having substantially rectangular members withstraight, substantially parallel, long edges. FIG. 4 illustrates asecond form of nasal dilator in accordance with the present invention:an overlaid resilient member structure that directs spring biasingforces to a wider area at the end regions of the truss. As in FIGS. 1and 2, a flat surface side of resilient member 22 b is overlaid onto 22a, and a flat surface side of resilient member 22 c is overlaid ontoresilient member 22 b. However, resilient member 22 a is wider at itsends and resilient member 22 b is narrower at its ends, as particularlyillustrated by broken lines and bracket in FIG. 5.

The spring biasing of a single resilient member in a dilator device isgenerally no greater than that determined by the width and thickness atthe resilient member mid-section. (Absent material separations, such asrelief cuts, openings, notches, etc., formed in the resilient member,greater width and/or thickness at its mid-section generally meansgreater spring biasing force, and narrower width and/or lesser thicknessat the resilient members ends generally lessens that spring biasingforce.) The wider end portions of resilient member 22 a thus do notnecessarily increase spring biasing force, but do spread the resilientmember spring constant across a greater lateral extent at the ends.Overlaid by resilient members 22 b and 22 c, however, the resiliency ofthe resilient member structure, as a whole, is increased. That increaseoccurs primarily along longitudinal centerline a, with the greatestspring biasing force generated at where the long edges of the overlaidresilient members are parallel to each other.

That increased resiliency is manipulated, or directed, at least in part,at end regions 32 and 34 of the truss; spread laterally by the increasedwidth of resilient member 22 a, and simultaneously decreased, at leastin part, by the tapered portions of resilient member 22 b. It will beapparent to one of ordinary skill in the art that the dimensions of thetapered portions of resilient members 22 b and 22 a are dynamic, and maybe adjusted or configured relative to each other, along with the overalldimensions of all resilient members, in order to achieve a desiredspring biasing constant and/or direction of spring biasing properties.

As seen in FIG. 4 b, each truss end region has elements associated withan end edge, 33, including: at least one tab extension, 35, at least onehorizontal protrusion 12, a material separation of various forms,including a notch, 13, and a valley, 12′. Protrusion 12 generallycorresponds to terminal end 23 of a resilient member, or as is the casein FIG. 4 b, corresponds to a portion of a′ resilient member end edge.Valley 12′ is generally interposed between two protrusions 12. Notch 13is interposed between tab extension 35 and an adjacent protrusion 12. Amaterial separation may also comprise a slit, back cut, indentation,slot, elongated opening, or other form, extending inward or outward froma peripheral edge (typically end edge 33) of the dilator, or from theend edge of a resilient member or other dilator layer.

End region elements may help the dilator conform to the contours ofnasal outer wall tissues, and as a directional element, may directspring biasing properties by changing the angle of focused springbiasing forces, at least in part, thus shifting or transforming at leastsome of these forces from primarily peel and tensile forces intoprimarily shear forces. The change in angle further redistributes orimparts said transformed forces to tissue engaging surface areas of theend regions, such as tab extensions 35, extending beyond the materialseparation. Spring biasing forces are thus imparted to the lateral widthand longitudinal extent of end regions 32 and 34, as opposed to agreater delaminating tendency from peel forces being imparted to alesser extent. Shear forces are more easily withstood by the tissueengaging adhesives disposed on the engagement element of dilator 10 thanare peel forces.

FIG. 4 c indicates the width, or lateral extent, d, of dilator 10 bybroken lines and a bracket. Lateral centerline, b, is also indicated bya broken line, and generally aligned to the bridge of the nose. Dilator10 is symmetric on each side of lateral centerline b, each horizontalhalf of dilator 10 being identical, one side being the mirror image ofthe other. Dilator 10 is also laterally symmetric on each side of itslongitudinal centerline a. However, dilator 10 may be laterallyasymmetric; end edge 33 and its associated elements may be angled inwardfrom one long edge of the dilator to the opposite long edge, forexample, making the upper long half of the dilator shorter than thelower long half so as to better correspond to the somewhat triangularshape of the nose.

FIG. 6 illustrates a method by which dilator resilient members 22 a and22 b, substantially as illustrated in FIG. 4, may be concurrentlyfabricated. FIG. 6 a shows a plurality of a continuous slit, 25, spacedacross the width of elongated web of resilient material, 24. Resilientmaterial 24 preferably has a layer of adhesive disposed on one sidecovered by a removable protective release liner. Continuous slits 25extend vertically through material web 24 and generally parallel to themachine direction thereof. Slits 25 form a plurality of elongatedresilient material strands, 26 a and 26 b. Each outside edge of web 24may include an outside waste strand, 27, the purpose of which is toallow for minor lateral drift of the material web or webs as they passthrough the die cutting machinery.

FIG. 6 a further illustrates that portions of the long edges ofresilient material strands 26 a and 26 b correspond to the long edges ofa plurality of resilient members 22 a and 22 b, respectively,interconnected end to end by waste pieces, 27′. Since strands 26 consistof a plurality of interconnected resilient members, then each continuousslit 25 forms, as well as defines, at least a portion of one long edgeof the interconnected resilient members adjacent to each side of theslit, the long edges of adjacent interconnected resilient members thusbeing on common lines.

By virtue that resilient material strands 26 a and 26 b alternatelaterally, side by side, their longitudinal centerlines are spacedequidistant, as indicated by broken lines and brackets. The strands arethus pre-registered to each other so that when separated into respectivegroups, as seen in FIG. 6 b, one group may be positioned squarely ontothe other group, as seen in FIG. 6 c, without having to align eachindividual strand. Dashed lines illustrate the respective ends ofinterconnected resilient members 22 a and 22 b, which are laterallyadjacent, thus their lateral centerlines b are aligned, as indicated bybroken lines. Accordingly, the interconnected resilient members arepre-registered to each other, both laterally and longitudinally, beforethe separated groups of resilient material strands are overlaid.

In FIG. 6 b, dashed lines illustrate the spaces in between resilientmaterial strands 26 a formerly occupied by strands 26 b. FIG. 6 c showsstrands 26 a, as a group, positioned onto a corresponding group ofstrands 26 b. Elongated resilient material strands 26 c, whichcorrespond to continuous interconnected resilient members 22 c, may beformed from a separate elongated web of resilient material, 24′, seen inFIG. 6 d. FIGS. 6 c and 6 d further illustrate that one strand 26 c outof a plurality thereof (each 1 in 5, as shown) aligns with and isoverlaid onto each of combined strands 26 a and 26 b. It will beapparent to the skilled practitioner that resilient material webs 24 and24′ may be of different thickness, and so also the respective elongatedstrands produced therefrom.

FIG. 6 e illustrates combined overlaid resilient material strands 26 a,26 b and 26 c laminated with at least one additional material webcorresponding to at least one additional layer of dilator 10 so as toform a fabrication laminate, 40. Laminate 40 may include at least one ofa base layer material web or cover layer material web and a protectiverelease liner. Prescribed die cut lines, 52, corresponding to theperipheral outline of finished dilator devices, extend verticallythrough fabrication laminate 40 to form finished dilators. In theprocess, die cut lines 52 sever strands 26 at the opposite end edges ofeach finished dilator device to form overlaid resilient member structure22.

FIG. 7 illustrates a third form of nasal dilator in accordance with thepresent invention wherein a narrower, substantially rectangular,resilient member 22 b is overlaid onto a portion of the width of a widerresilient member 22 a. Resilient member 22 a includes at least threepairs of spring finger components, 22′, extending longitudinally outwardfrom a common center to terminal ends 23. This resilient memberstructure approximates that of three adjacent parallel, substantiallyrectangular resilient member bands, and wherein at least one band has agreater thickness. In the present instance, that greater thickness isprovided by overlaid resilient member 22 b, which extends substantiallyparallel to resilient member 22 a.

Spring fingers components 22′ are defined, at least in part, by materialseparations in the form of a slit, 21, extending inward from the endedges of resilient member 22 a. Spring fingers 22′ could alternativelybe separated by a slot or elongated opening, which would then definelateral spacing, or distance, between the spring finger inside longedges. Spring fingers 22′ may be of any length or width so as toinfluence or direct resilient properties independently to each long halfof the resilient member. However, they are preferably substantiallyuniform. Depending upon the length of slits 21, resilient member 22 amay have greater axial, torsional flexibility along its length,particularly near its ends. Greater flexibility generally allows dilator10 to more closely conform to surface irregularities of the nasal outerwall tissues.

Resilient member 22 b is preferably longitudinally aligned to at leastone spring finger 22′, its width preferably no greater than the width ofthe spring finger overlaid, so as to add its thickness thereto andincrease resiliency along thereat. FIG. 7 d more particularlyillustrates resilient member 22 b being slightly narrower than the widthof the pair of opposing spring finger components 22′ onto which it isoverlaid. As shown, resilient member structure 22 is configured so thatdilator 10 generates greater spring biasing force along centerline a.Alternatively, resilient member 22 b may be longitudinally aligned to atleast one slit 21 so as to divide its width across two or more springfinger components.

FIG. 7 d also shows the engagement element, e, of dilator 10 representedby dashed lines in the form of the dilator periphery. Engagement elemente may comprise any layer, or portion thereof, or any combination oflayers that make up the engagement element, as described hereinbefore.The dilator engagement element is occasionally referenced in this mannerin some embodiments of the present invention to particularly illustratefeatures and construction of the dilator functional element in the formof resilient member structure 22 and the constituent resilient membersthereof. The reference symbol e may alternatively indicate that thedilator engagement element may be optional; the resilient memberstructure thus forming the truss substantially in its entirety, asdescribed hereinbefore.

FIG. 8 illustrates that dilator resilient members 22 a and 22 b,particularly as seen in FIG. 7, may be concurrently fabricated alongcommon die cut lines substantially as described previously with respectto FIG. 6. A plurality of continuous slit 25 spaced across a web ofresilient material 24 forms alternating resilient material strands 26 aand 26 b, as indicated by broken lines and brackets. The long edges ofthe strands correspond to the long edges of a plurality of successiveinterconnected resilient members 22 a and 22 b, as indicated by brokenlines and dashed lines.

By virtue that resilient material strands 26 a and 26 b alternate sideby side, their longitudinal centerlines are spaced equidistant. Whenseparated into respective groups, one group may be overlaid squarelyonto the other without having to align individual strands. The alignedoverlaid strands may be combined with at least one additional materialweb corresponding to at least one additional layer of dilator 10 so asto form a fabrication laminate from which finished dilator devices aredie cut.

FIGS. 9 and 10 illustrate a fourth form of nasal dilator in accordancewith the present invention, wherein a portion of a flat surface side ofat least one resilient member overlaps a portion of a flat surface sideof at least one other resilient member. At least one long edge of oneresilient member intersects a long edge of another resilient member.FIG. 9 shows that resilient members 22 a and 22 b overlap by crossing attheir respective mid-sections. Each resilient members has the same widthand parallel long edges; the shape of overlap surface area 20 is thus aparallelogram or rhombus. Substantially rectangular resilient membersmay cross in the form of an X, as shown in FIG. 9, or alternatively,resilient members having a rectangular mid-section and divergent endportions may overlap along said mid-sections and cross, as shown in FIG.10 b, or not cross, as shown in FIG. 10 a.

The width of the resilient members, the angle at which they cross, orthe angle at which said end portions diverge, is dynamic, and may beconfigured to direct resilient properties in a predetermined manner.Furthermore, the size and peripheral dimensions of overlap surface area20 are influenced by the respective widths of the resilient members (anarrower width forms a lesser overlap surface area; a greater widthforms a greater portion), by the angle at which the resilient memberscross (a greater crossing angle forms a lesser overlap surface area; anarrower angle forms a greater portion), or by the degree of angle atwhich opposite ends of the resilient member diverge from themid-section. It will be apparent to one of ordinary skill in the artthat resilient members of a different shape or width would change theshape or size of overlap surface area 20 accordingly.

The longitudinal extent and peripheral shape of overlap surface areas 20as seen in FIGS. 9 and 10 are particularly illustrated in FIG. 11: FIG.11 a corresponds to the dilator illustrated in FIG. 9; FIG. 11 bcorresponds to FIG. 10 b, and FIG. 11 c corresponds to FIG. 10 a. FIG.11 shows that as overlap surface area 20 extends progressively moretoward the opposite end edges of dilator 10 there is correspondinglyless lateral separation between respective resilient member terminalends 23 at the opposite end edges of the truss, to the point where thereis no lateral separation at all, as in FIG. 11 c.

As seen in FIGS. 9 and 10, overlapping resilient member structuresinclude non-overlap surface areas comprising spring finger componentsextending outward from a common center of greater thickness, the commoncenter defined by overlap surface area 20. The spring biasing forcegenerated by the resilient member structure is thus spread laterally andoutward to four discrete engagement contact points that correspond torespective resilient member terminal ends 23 (which also corresponds totruss end edge element protrusion 12). As indicated by broken lines andbrackets in FIG. 9 c, the upper contact points may be positioned on thenose adjacent the nasal valve, the lower contact points over the nostrilarea or nasal vestibule.

FIG. 10 a illustrates that resilient members 22 a and 22 b may overlapwithout crossing. The resilient members are identical, but flippedlaterally from each other. Instead of crossing, the resilient membersoverlap along their mid-sections, with the two divergent end portions ofeach resilient member being on the same side of longitudinal centerlinea. Overlap surface area 20 has parallel long edges and the shape of ahexagon or six-sided polygon. By comparison, the end portions of theresilient members in FIG. 10 b diverge to each side of the long edges ofthe overlaid mid-sections. The dilators of FIGS. 10 a and 10 b arefurther illustrated in the plan view in FIG. 10 c.

In overlapping resilient member structures, one resilient member mayhave greater resiliency than the other, such as by greater thickness orwidth. As seen in FIGS. 9 a and 9 c, for example, if resilient member 22a is thicker than resilient member 22 b, outer wall tissues above thenasal valve would be subject to greater spring biasing, while tissuesaround the nostril would have lesser spring biasing. The reverse wouldbe true at the opposite end region of the truss on the other side of thebridge of the nose. If the resilient members overlap, but do not cross,as shown in FIG. 10 a, spring biasing at respective resilient memberterminal ends would be the same at each end region of the truss, andthus the same on each side of the bridge of the nose.

Resilient member structures like those illustrated FIGS. 9-11 may befabricated substantially as discussed previously with respect to FIG. 6,with the difference, as seen in FIG. 12, that elongated resilientmaterial strands 26 a and 26 b are configured so as to overlap, orcross, in a continuous pattern. The strands are preferably identical,and are labeled “26 a” and “26 b” for descriptive clarity.

Elongated resilient material strands 26 a and 26 b are slit fromrespective resilient material webs 24 and 24′, which are aligned to atleast one additional material web corresponding to fabrication laminate40. All webs are shown fragmentary. FIG. 12 illustrates that each strand26 a and 26 b include repeating portions that extend parallel to thelong edges of fabrication laminate 40, and portions that divergeobliquely therefrom. For illustrative clarity, resilient material webs24′ and 24 are depicted as being on opposite sides of laminate 40. Inpractice, the webs would be positioned relative to each other and tolaminate 40 so that a group of select strands 26 a and 26 b, from xplurality thereof (as shown, each 1 of 6 or each 1 of 7) may be peeledfrom the respective webs and incorporated into laminate 40 such that therepeating portions of the strands cross in a continuous pattern.

The lengths of resilient material webs 24 and 24′ and the at least oneadditional material web corresponding to laminate 40 are preferably verysimilar. Webs 24 and 24′ must be shifted slightly to re-align withlaminate 40 as each group of 1 from x number of resilient materialstrands 26 and 26 a are peeled away. Once the desired resilient layerstrands 26 and 26 a are overlapped and incorporated into laminate 40,prescribed die cut lines 52, corresponding to the peripheral outline offinished dilator devices, extend vertically through fabrication laminate40 to form finished dilators. In the process, die cut lines 52 severstrands 26 at the opposite end edges of each dilator device to formoverlapping resilient member structure 22. Laminate 40 may include atleast one of a base layer material web or a cover layer material web,and a removable protective release liner, as described hereinbefore.

FIG. 12 a applies particularly to the resilient member structure seen inFIG. 9. As such, the overlaid portions of resilient material strands 26a and 26 b correspond to the aforementioned portions that divergeobliquely. FIG. 12 b illustrates the resilient member structure seen inFIG. 11 b as an example, in which case the overlaid portions of thestrands correspond to those portions that are parallel to the long edgesof the web. In either case, FIG. 12 illustrates that the continuouscrossing pattern forms a plurality of an overlapping resilient memberstructure in which the non-overlap surface areas comprise spring fingercomponents extending outward from a common center; the common center inturn defined by the overlap portion, as described previously. This typeof overlapping resilient member structure is also discussed with regardto FIGS. 15, 17, 20-22, and 23-25, all of which may be fabricated by themethod of FIG. 12.

FIG. 13 illustrates a fifth form of nasal dilator in accordance with thepresent invention, depicting overlaid resilient member structuressimilar to the overlapping resilient member structures of FIG. 11. Inparticular, FIG. 13 a corresponds to FIG. 11 a; FIG. 13 b to FIG. 11 b,and FIG. 13 c to FIG. 11 c. The overall configuration of overlap andnon-overlap surface areas, and the resilient properties of therespective resilient member structures of one embodiment areeffectively, or alternatively, re-created in the other.

Each resilient member 22 a seen in FIG. 13 has a peripheral outline atleast similar, if not identical, to the periphery of the combinedoverlapped resilient members 22 a and 22 b of FIG. 11. Accordingly,resilient member 22 a, as seen in FIGS. 13 a and 13 b, is formed toinclude spring finger components 22′ extending outward from a commoncenter to discrete engagement contact points at each end region of thetruss. Resilient member 22 a may also be viewed as including a materialseparation in the form of a roughly triangular shaped opening extendinginward from each end edge. The opening defines the inside long edges ofthe spring finger components and the lateral separation between upperand lower discrete contact points. While the configuration of resilientmember 22 a is shown similar to the peripheral outline of the resilientmember structure shown in FIG. 11, spring finger components 22′ mayalternatively be any shape or configuration: straight, curved, or havinga constant or tapered width.

FIG. 13 further illustrates resilient member 22 b, having the respectiverhombus or hexagon shape of overlap surface area 20 seen in FIG. 11,overlaid and centrally registered with, or island-placed onto, resilientmember 22 a, extending between the opposing points at which springfinger components 22′ diverge. (Note that the structure of FIG. 13 c isgenerally similar to that of FIG. 4, discussed previously.) Respectiveresilient member thickness being equal, the resilient member structuresof FIGS. 9-11 and FIG. 13 will have similar spring biasing properties.Both structures and their corresponding engagement elements may beefficiently converted into dilator devices using methods substantiallyas described herein.

As previously discussed with regard to FIG. 7, the spring biasing of asingle resilient member in a dilator device corresponds to the narrowestwidth at its mid-section. Resilient member 22 a seen in FIG. 13 is widerat its ends, having greater width, or cumulative width, than at itsmid-section. The wider ends of resilient member 22 a laterally spreadthe spring biasing force generated by the combination of resilientmembers 22 a and 22 b. Resilient member 22 b increases thickness, andthus resiliency, of resilient member structure 22.

FIG. 14 illustrates a method of fabricating a plurality of a centrallyregistered, or island-placed, resilient member structure, particularlyas seen in FIGS. 13 a and 13 b. It will be apparent to one of ordinaryskill in the art that while the resilient member structures shown inFIGS. 13 a and 13 b are exemplified, the manufacturing method isapplicable to any number of similar resilient member structures.

FIG. 14 a illustrates enclosed die cut lines 25′ extending throughresilient material web 24 to, but not through, its protective releaseliner, kiss cutting a plurality of spaced apart resilient members 22 b.Resilient material web 24 preferably has a layer of adhesive on at leastone flat surface side covered by the liner. The resilient materialextending around and between the kiss cut resilient members is removedand layered onto a separate protective release liner, 41, as indicatedby broken lines, leaving resilient members 22 b releasably secured onthe original release liner of material web 24. Dashed lines illustratewhere the original liner will be slit into a plurality of elongatedstrips 28 a, each strip comprising a plurality of resilient members 22b. Layering the separated resilient material matrix on liner 41effectively forms a second resilient material web, labeled 24′ forclarity.

As a practical matter, resilient material web 24′ is the same asresilient material web 24, albeit including a plurality of openingscorresponding to the previously kiss cut resilient members 22 b. Dashedlines in resilient material web 24′ represent where continuous slits 25will form adjacent rows of elongated resilient material strands 26 a, asmore particularly illustrated in FIG. 14 b. Additionally, dashed linesrepresent where enclosed die cut lines 25′ will form additionalresilient members 22 c within each strand 26 a. The long edges ofstrands 26 a, formed by continuous slits 25, define additional resilientmembers, 22 d, adjacent the openings left by resilient members 22 b.

FIG. 14 b illustrates elongated resilient material strands 26 a kiss cutand removed from release liner 41, of resilient material web 24′, asindicated by broken lines. The removed strands 26 are shown slightlyspaced apart to indicate that while they were die cut in part alongcommon lines, and thus abut, they are not attached to each other. Theremoved resilient material strands 26 a leave behind a plurality ofspaced apart additional resilient members 22 c and 22 d releasablysecured on protective liner 41. Outside waste strand 27 is formed alongeach long edge thereof, in which some resilient members 22 b werepreviously kiss cut. (Resilient members 22 d could conceivably be formedaround those openings as well.) Dashed lines in release liner 41illustrate where the release liner will be slit into elongated strips 28b and 28 c, each strip comprising a plurality of resilient members 22 cor 22 d, respectively, as more particularly illustrated in FIG. 14 d.

FIGS. 14 a-14 c show resilient material strand 26 a comprising aplurality of successive interconnected resilient members 22 a. Resilientmember 22 b is formed in resilient material web 24 immediately adjacentthe mid-section of each interconnected resilient member 22 a. As aresult, the spaced apart resilient members 22 b and the portions ofstrands 26 a corresponding to finished resilient members 22 a areeffectively pre-registered to each other longitudinally, center tocenter. The process also renders resilient members 22 c and 22 d spacedlongitudinally equidistant, and thus pre-registered to each other.

Turning now to FIG. 14 c, each resilient material strand 26 a isoverlaid onto elongated strip 28 a so that each resilient member 22 b isaligned with each interconnected resilient member 22 a, as indicated bybroken lines and dashed shadow lines. The overlaid resilient members maybe secured to each other by use of intermediate layer material web, 16′,also represented by dashed lines (and from which intermediate layer 16,interposed between resilient members as described hereinbefore, would beformed). The overlaid resilient members may be combined with at leastone additional material web to form laminate 40 from which finisheddilators are die cut, as represented by dashed lines. Die cut lines 52form finished dilators, severing strands 26 a into individual resilientmembers 22 a in the process.

Similarly, FIG. 14 d shows elongated strips 28 b and 28 c, whichcomprise additional resilient members 22 c and 22 d, respectively,overlaid and aligned to each other, as indicated by broken lines. Onestrip must be flipped over so that the respective resilient members fromboth strips face each other. Again, resilient members 22 c and 22 d werepre-registered to each other longitudinally, center to center, when diecut from resilient material web 24′. And again, the resilient membersmay be secured to each other by use of intermediate layer material web16′.

The overlaid resilient members are combined with at least one additionalmaterial web to form laminate 40 from which finished dilators are diecut, as represented by dashed lines. Die cut lines 52 extend outboardthe periphery of the overlaid resilient members, but preferably sever,or ‘round off’ the pointed ends of resilient members 22 d in theprocess. The overlaid resilient members are otherwise substantiallyisland-placed within the peripheral edges of each finished dilatordevice.

FIG. 15 shows a sixth form of nasal dilator in accordance with thepresent invention. Arcuate resilient members 22 a and 22 b overlap alonga portion of their respective mid-sections. Non-overlap surface areasdefine spring finger components extending outward from a common center,defined by overlap surface area 20, to discrete engagement contactpoints. Overlap surface area 20 has curved long edges and a gradientlyreduced width from its mid-section to each end. The radial curvature ofone resilient member may be the same, lesser, or greater than the other.The long edges of dilator 10, including the long edges of upper andlower tab extensions 35, generally follow the curvature of the resilientmembers.

FIG. 15 further illustrates that one resilient member may be longer thanthe other member. In the present embodiment, resilient member 22 b islonger than resilient member 22 a, and thus lower tab extensions 35extend slightly beyond the upper tab extensions 35. The truss's end edgeelements generally follow an inward angle, as indicated by broken lines,to better correspond to shape of the nose. If both resilient members arethe same width and thickness, spring biasing forces would becorrespondingly greater along the upper long half of the device. (Springbiasing forces may be equalized by having the shorter resilient membercorrespondingly narrower or thinner.) At each end edge 33, terminal endportions 23 correspond to respective protrusions 12, with valley 21therebetween. Protrusions 12 are preferably separated from tabextensions 35 by a material separation formed therebetween, as describedhereinbefore.

Dilator 10 also features a distinct lateral separation between upper andlower discrete contact points, and also between the truss width alonglateral centerline b and the lateral separation between upper and lowertab extensions 35. A narrower intermediate region means less potentiallyirritating adhesive engagement surface area across the bridge of thenose, the skin thereat less likely to be irritated upon removal of thedevice. (For some people the skin across the bridge of the nose is moresensitive to removal of adhesively attached medical devices. Minimizingdevice surface area or adhesive contact thereat can thus make a devicemore comfortable.)

The lateral separation between tab extensions, or the lateral extent d,of dilator 10, spreads spring biasing forces to a greater surface areaof the nasal outer wall tissues. The extent of lateral separationbetween upper and lower contact points, roughly center-to-center, isabout 2.7 times greater than the width of overlap surface area 20; thelateral extent d of dilator 10 is about six times greater than the widthof overlap surface area 20, and about 3.7 times greater than the widthof intermediate region 36 at its narrowest point, at lateral centerlineb. At the same time, the length, or longitudinal extent, of overlapsurface area 20 is substantial, relative to the overall length of thetruss, being equal to about 60% thereof.

FIG. 16 illustrates a seventh form of nasal dilator in accordance withthe present invention, illustrating an overlaid resilient memberstructure alternative to the overlapping resilient member structure seenin FIG. 15. The overall configuration of overlap and non-overlap surfaceareas, and the resilient properties of the respective resilient memberstructures of one embodiment are effectively, or alternatively,re-created in the other. Respective resilient member thickness beingequal, the resilient member structure of FIGS. 15 and 16 will havesimilar spring biasing properties. Both structures and theircorresponding engagement elements may be efficiently converted intodilator devices using methods substantially as described herein.

Resilient member 22 a of FIG. 16 has a peripheral outline at leastsimilar, if not identical, to the periphery of combined overlappedresilient members 22 a and 22 b as seen in FIG. 15. Resilient member 22a is formed to include spring finger components 22′ curving outward froma common center to discrete engagement contact points, as describedhereinbefore. Resilient member 22 a may also be viewed as including amaterial separation in the form of a roughly triangular shaped openingextending inward from each end edge. The opening defines the inside longedges of the spring finger components and the lateral separation betweenupper and lower discrete contact points. Resilient member 22 b havingsubstantially the shape of overlap surface area 20 as seen in FIG. 15,is overlaid so as to be centrally registered with, or island-placedonto, resilient member 22 a.

FIG. 17 illustrates a eighth form of nasal dilator in accordance withthe present invention. Resilient member 22 b, having a substantiallyrectangular mid-section and divergent end portions, overlapssubstantially rectangular resilient member 22 a such that non-overlapsurface areas define spring finger components extending outward from acommon center, defined by overlap surface area 20, to discreteengagement contact points. Overlap surface area 20 is thus shapedgenerally as a trapezoid or four-sided polygon. Resilient member 22 bmay be configured so that its divergent end portions extend slightlybeyond terminal ends 23 of resilient member 22 a. FIG. 17 d illustratesthat dilator 10 may be optionally positioned on the nose with thedivergent end portions angled upward so as to engage tissues at or nearwhere the nose meets the cheek, as indicated by a broken line.

FIG. 18 illustrates a ninth form of nasal dilator in accordance with thepresent invention, illustrating an overlaid/island-placed resilientmember structure alternative to the overlapping resilient memberstructure seen in FIG. 17. The overall configuration of overlap andnon-overlap surface areas, and the resilient properties of therespective resilient member structures of one embodiment areeffectively, or alternatively, re-created in the other.

Resilient member 22 a of FIG. 18 has a peripheral outline at leastsimilar, if not identical, to the periphery of the combined overlappedresilient members 22 a and 22 b of FIG. 17, including spring fingercomponents 22′ that diverge at an oblique angle and extend to discreteengagement contact points. Resilient member 22 a may also be viewed asincluding a material separation in the form of a roughly triangularshaped opening extending inward from each end edge. The opening definesthe inside long edges of the spring finger components and the lateralseparation between upper and lower discrete contact points. Resilientmember 22 b, having substantially the shape and position as overlapsurface area 20 seen in FIG. 17 b, is overlaid and centrally registeredwith, or island-placed onto, resilient member 22 a. Respective resilientmember thickness being equal, the resilient member structure of FIGS. 17and 18 will have similar spring biasing properties. Both dilator devicesmay be efficiently converted using methods substantially as describedherein.

As discussed previously, the intermediate region of dilator 10 isnarrower than the lateral separation of resilient member terminal ends23. In FIGS. 17 and 18 the width of the lateral separation between upperand lower contact points, roughly center-to-center, is about 2.6 timesgreater than the width of overlap surface area 20; the overall width ofdilator 10 is about 5.5 times greater than the width of overlap surfacearea 20 and about 3.8 times greater than the width of intermediateregion 36. The longitudinal extent of overlap surface area 20 in FIG. 17or resilient member 22 b of FIG. 18 is about 64% of the resilient memberstructure's overall length.

FIG. 19 illustrates a method of fabricating resilient members 22 a and22 b, particularly as seen in FIG. 18, concurrently from resilientmaterial web 24. Web 24 preferably includes a layer of adhesive disposedon one flat surface side covered by a removable protective releaseliner. FIG. 19 a shows that a plurality of continuous slits 25 formadjacent rows of resilient member strands 26 a. Enclosed die cut lines25′ are positioned in between slits 25 so as to form a plurality ofsuccessive spaced apart resilient members 22 b within each strand 26 a.Each outside edge of web 24 may include outside waste strand 27.

FIG. 19 a further illustrates that the long edges of resilient materialstrand 26 a correspond to the long edges of a plurality of successiveinterconnected resilient members 22 a; dashed lines represent terminalends 23 thereof. Strand 26 a, and thus resilient members 22 a and 22 b,are configured so that their long edges nest along common die cut linesformed by continuous slits 25 and enclosed die cut lines 25′. Brokenlines at the top of FIG. 19 a indicate how a pair of strands 26 a nesttogether. Rows of two nested strands also abut along common die cutlines formed by slits 25.

FIG. 19 b illustrates resilient material strands 26 a separated from theprotective liner of resilient material web 24, leaving a plurality ofspaced apart resilient members 22 b thereon. Dashed lines illustratewhere the release liner will be slit into a plurality of elongatedstrips 28 a, each strip comprising a plurality of resilient members 22b, as more clearly seen in FIG. 19 c. Again, strand 26 a and resilientmembers 22 a and 22 b are configured so that elongated strip 28 a alignswith resilient material strand 26 a such that resilient members 22 b arecentrally registered, or island-placed onto resilient members 22 a, asindicated by broken lines and dashed shadow lines in FIG. 19 c.

Overlaid resilient material strands 26 a and elongated strips 28 a maybe combined with at least one additional material web corresponding toat least one additional layer of the dilator to form a fabricationlaminate as described hereinbefore. Die cut lines extend verticallythrough the fabrication laminate, forming finished dilator devices andsevering strands 26 a in the process.

FIGS. 20-22 illustrate three examples, from myriad possible, of a tenthform of nasal dilator in accordance with the present invention. Theapproximate form of dilator 10 as seen in FIG. 17 is essentiallyduplicated and flipped laterally, making two parts as the mirror imageof each other, each part representing one long half of a single unit.Thus resilient members 22 b and 22 c, formed to include divergent endportions, overlap rectangular resilient member 22 a to createnon-overlap surface areas formed as spring finger components extendingoutward from a common center, defined by overlap surface area 20, todiscrete engagement contact points. The drawing figures are arranged tofacilitate comparative analysis of the examples given, particularly theresilient member structures thereof.

Resilient members 22 b and 22 c may have the same or similar shape aseach other. Their rectangular mid-sections may abut, may be adjacent,spaced apart, or overlap. The divergent end portions of each resilientmember are on the same long side of resilient member 22 a, and thus theresilient members overlap but do not cross. The resilient members mayoptionally overlap and cross, as described hereinbefore, particularlywith regard to FIG. 10 b. The divergent end portions may diverge at thesame, or similar, oblique angle. Resilient member 22 c is generallyrectangular, but may have gradiently tapered end portions as seen inFIG. 22. A fourth, substantially rectangular, resilient member, 22 d,may be optionally added to the resilient member structure as illustratedin FIGS. 22 b and 22 d. The resilient members preferably have a single,constant thickness, however each individual resilient member may be thesame or different thickness than any other resilient member.

Overlap surface areas 20 are more particularly illustrated in FIGS. 20c, 21 c and 22 c. FIG. 20 c shows overlap surface area 20 along eachside of the longitudinal centerline of the truss, having a combinedthickness of two resilient members (22 c plus 22 a, and 22 b plus 22 a,respectively). A third overlap surface area 20, also indicated in FIG.20 d, is formed by the combined thickness of all three resilientmembers. As seen in FIG. 22 d, an optional fourth resilient member, 22d, may overlap the seam where a long edge from each of adjacentresilient members 22 b and 22 c abut. An overlap surface area having acombined thickness of three resilient members, not shown, thuscorresponds to the width of resilient member 22 d extending along saidseam.

By virtue of the resilient member structures' divergent end portions,there is a distinct lateral separation between discrete contact pointsdefined by upper and lower resilient member terminal ends 23. Overlapsurface areas 20 are from about two to five times narrower than thelateral separation of the outermost contact points, and from about threeto six times narrower than the lateral extent of each dilator endregion. The length of overlap surface areas 20 range from about 50% toabout 64% of the total length of the truss.

FIGS. 23-25 illustrate examples, from myriad possible, of an eleventhform of nasal dilator in accordance with the present invention. Dilator10 has substantially parallel long edges from end to end, the resilientmember structures having substantially rectangular peripheries andparallel long edges. However, individual resilient members 22 a and 22 bare irregularly shaped, being wider at their mid-sections and narrowerat each terminal end. The drawing figures are arranged so as tofacilitate comparative analysis of FIGS. 23, 24 and 25 to each other.

Resilient members 22 a and 22 b may be configured to overlap and cross,or alternatively, to overlap without crossing, as describedhereinbefore. In either case, overlap surface area 20 extends at leastalong intermediate region 36, the resilient members having widermid-sections that taper to narrower ends defined by terminal ends 23.Accordingly, the non-overlap surface areas comprise comparativelyshorter spring finger components extending horizontally outward from thecommon center defined by overlap surface area 20.

As seen in FIG. 23, resilient members 22 a and 22 b are configured toform overlap surface area 20 as a diamond or rhombus shape with agradiently reduced width extending horizontally outward from lateralcenterline b. Upper and lower spring finger components, as defined bynon-overlap surface areas, extend horizontally outward from the taperedupper and lower long edges of overlap surface area 20.

FIG. 24 shows that resilient members 22 a and 22 b overlap along aportion of the width of their respective elongated mid-sections. Overlapsurface area 20 is thus formed as a relatively narrow band extendingsubstantially from one truss end region to the other. This resilientmember structure approximates that of two substantially parallelresilient member bands positioned adjacent one another and overlaid by athird, island-placed or centrally registered resilient member (analternative configuration as illustrated substantially in FIG. 27 a tofollow).

FIG. 25 illustrates resilient members 22 a and 22 b configured to formoverlap surface area 20 as a six-sided polygon. The entire width of theresilient members' elongated mid-sections overlap. The comparativelyshorter tapered edges of overlap surface area 20 are positioned roughlyat the intersection of intermediate region 36 and respective end regions32 and 34. FIG. 25 also illustrates a third resilient member 22 c thatforms an additional overlap surface area 20 equal to the combinedthickness of all three resilient members. There are thus two overlapsurface areas 20 having a second thickness, plus a centrally registeredoverlap surface area 20 having a third thickness (non-overlap surfaceareas being a first thickness, assuming all resilient members are equalthickness, as discussed hereinbefore).

FIGS. 26-27 illustrate twelfth and thirteenth forms of a nasal dilator,respectively, in accordance with the present invention, illustratingisland-placed resilient member structures as alternatives to theoverlapping resilient member structures seen in FIGS. 23-25. Inparticular, FIG. 23 corresponds to FIG. 26 a, FIG. 24 corresponds toFIG. 26 b, and FIG. 25 corresponds to FIGS. 26 c/26 d. FIGS. 27 a and 27b illustrate resilient member structures as a further alternative tothose shown in FIGS. 26 b and 26 c/26 d, respectively. Comparisons ofsimilarities and differences between respective resilient memberstructures may also be made between FIGS. 26 a and 26 b; between FIGS.26 b and 27 a; between FIGS. 27 a and 27 b, and between FIGS. 26 c and27 b.

The peripheral outlines of resilient members 22 a seen in FIG. 26 are atleast similar, if not identical, to the respective peripheries ofcombined overlapped resilient members 22 a and 22 b as seen in FIGS.23-24, or resilient members 22 a, 22 b and 22 c as seen in FIG. 25.Resilient members 22 a as shown in FIG. 26 have parallel long edges anda generally rectangular shape. A material separation in the form of anotch or elongated opening extends inward from each end edge of theresilient member, defining the interior long edges of, and lateralspacing between, the spring finger components adjacent thereto. In FIG.26 d, the lateral separation is wide enough to encompass the width ofresilient member 22 c.

Resilient member 22 b, having substantially the shape and position ofoverlap surface areas 20 as seen in FIGS. 23-25, is centrallyregistered, or island-placed, onto resilient member 22 a. The resilientmember structures of FIGS. 26 c and 26 d include a third, substantiallyrectangular resilient member 22 c positioned substantially alongcenterline a; in FIG. 26 c, it extends along the intermediate region ofthe truss, and in FIG. 26 d extends the length of the truss. (Thedilator device of FIG. 26 c is somewhat similar to that discussedpreviously with regard to FIG. 7.)

FIGS. 27 a and 27 b illustrate further alternative resilient memberstructures to those shown in FIGS. 26 b and 26 c/26 d, respectively. Atleast one island-placed or centrally registered resilient member, 22 cor 22 d, overlays two or three substantially parallel adjacent resilientmembers. The width of the overlaid resilient member straddles at leastone longitudinal space between the inside long edges of at least twoparallel resilient members. An island-placed resilient member overlaidin this manner may be of any shape preferably confined to within theperipheral outline of the resilient member structure as a whole.

As illustrated and described, the dilator devices of resilient memberstructures of FIGS. 23-25 have similar spring biasing propertiescompared to the corresponding alternative resilient member structures ofFIGS. 26 and 27, respective resilient member thickness being equal. Bothsets of resilient member structures and their corresponding engagementelements may be efficiently converted into dilator devices using methodssubstantially as described herein.

FIGS. 28 and 29 illustrate a fourteenth form of nasal dilator inaccordance with the present invention. Resilient member 22 a is formedto include spring finger components 22′ extending outward from a commoncenter at its mid-section to discrete engagement contact points at eachend region of the truss. Resilient member 22 a may also be viewed asgenerally rectangular and including a material separation in the form ofan elongated opening extending inward from each end edge. The materialseparation bifurcates resilient member 22 a, defining the inside longedges of the spring finger components and the lateral separation betweenupper and lower discrete contact points.

The spring finger components may have a constant or tapered width, theymay be parallel to each other or diverge, or they may be uniform orasymmetric. The common center extends horizontally along at least aportion of the intermediate region of the truss, overlaid by resilientmember 22 b thereat. Terminal ends 23 of resilient member 22 b mayextend longitudinally to, past, or alternatively, short of, terminalends 23 of spring finger components 22′. Similarly, terminal ends 23 ofeither resilient member 22 a or 22 b may extend to the lateral end edgesof the truss, or alternatively, extend short thereof. The width ofresilient member 22 b at its mid-section preferably corresponds to thelateral spacing between upper and lower spring finger components.

FIGS. 30-32 illustrate examples, from myriad possible, of a fifteenthform of nasal dilator in accordance with the present invention.Resilient member structure 22 comprises a plurality thin resilientmembers of progressively less length arranged in a leaf spring manner,creating a stepped reduction from greater to lesser thickness. Thecumulative resiliency of the stacked resilient member mid-sectionsextends longitudinally outward from lateral centerline b to where it isreduced along the length of the successive steps at each end region, asindicated by directional arrows. The number of steps corresponds to thenumber of overlaid resilient members. (Note that a stepped reduction inthickness extending laterally outward from longitudinal centerline a wasdiscussed previously with respect to FIG. 2.)

The stepped reduction in resilient member structure thickness creates acorresponding stepped reduction in resiliency, a designed directionalelement of dilator 10, whereby to decrease spring biasing peel forces atthe end regions of the truss, particularly in view of the resilientmember structure's engineered spring constant as compared to that of asingle member resilient structure (or two closely parallel resilientmembers). Individual resilient members preferably have the samethickness. However, to add a further dynamic element, some or allresilient members may be of greater or lesser thickness.

To generate a suitable range of spring biasing force, a single resilientmember (or two adjacent, parallel, resilient members) have a length, awidth, and a constant thickness along said length. To generate the same,similar, or greater range of spring biasing force, the plurality ofstacked resilient members comprising the leaf spring structure may havethe same or similar width as the single or two parallel members, butonly a proportional fraction of thickness. Determining said proportionalfraction of thickness should take into account the correspondingincrease in resiliency for each stepped reduction in length, anycompounding effect created by virtue of there being a plurality ofstacked or overlaid members, and the maximum spring constant that may begenerated given the reduction thereof at each end region.

FIGS. 30 and 31 particularly illustrate that resilient member structure22 has enlarged end portions, formed by tapered long edges of theconstituent resilient members in FIG. 30, and by the radial curvature ofone long edge of each resilient member in FIG. 31, the latter of whichserves to spread spring biasing both laterally and away fromlongitudinal centerline a, roughly at an oblique angle thereto asindicated by broken lines. FIG. 31 c illustrates dilator 10 positionedon the nose with the divergent portion of the end regions positioned up,so as to engage tissues at or near where the nose meets the cheek asindicated by a broken line. Alternatively, the device may be positionedon the nose with the divergent portion down, extending over the nostrilor nasal vestibule.

FIGS. 31 a and 31 c also illustrates that resilient member structure 22may optionally include a plurality of small interior materialseparations in the form of openings, 13′, positioned so as toselectively reduce resiliency. Openings may extend vertically throughall layers of the dilator so as to make the device more breathable byallowing moisture vapor to pass vertically through the openings, awayfrom the skin.

FIG. 32 illustrates a leaf spring structure applied to two, oralternatively, three, adjacent, substantially rectangular, parallelresilient members. FIG. 32 a illustrates an even and symmetric steppedreduction in length; FIG. 32 b illustrates that the stepped reduction inlength, and the number of constituent resilient members thereof, mayvary.

The stepped reduction in thickness preferably extends along therespective end regions of the truss, as indicated approximately bybroken lines in FIGS. 30-32, but may optionally extent into theintermediate region. The progressive reduction in length may be uniformor disparate, in either or both end regions. It will be apparent to oneof ordinary skill in the art that resilient member structure 22 of FIGS.30-32 is roughly analogous to, or otherwise an alternative to, a singleresilient member being sculpted or formed so as to have the same orsimilar vertical profile of stepped, reduced thickness.

FIGS. 33 and 34 illustrate a sixteenth form of nasal dilator inaccordance with the present invention. The previously described steppedreduction in resilient member thickness and corresponding reduction inresiliency is spread both laterally across the width, and horizontallyalong the length, of each end region of the truss. FIG. 33 illustratesresilient member structure 22 having at least one substantiallyrectangular resilient member overlaid by a plurality of resilientmembers having a substantially rectangular mid-section and divergent endportions. FIG. 34 illustrates resilient member structure 22 havingidentical resilient members progressively offset relative tolongitudinal centerline a and/or lateral centerline b in a staggeredoverlapping relationship. The constituent resilient members of eitherresilient member structure 22 may be stacked in any order. Individualresilient members preferably have the same thickness. However, to add afurther dynamic element, some or all resilient members may be of greateror lesser thickness.

FIG. 33 further illustrates individual resilient members havingdivergent end portions that overlap and cross, as describedhereinbefore. Their mid-sections are substantially overlaid and theirdivergent end portions are on opposite sides of longitudinal centerlinea. The divergent end portions may optionally be on the same side oflongitudinal centerline a, also as described hereinbefore, withoutdeparting from the intended configuration of resilient member structure22. In either case, the angle at which the end portions diverge from themid-section is varied and stepped in a fanfold-like manner so that thecumulative resiliency of the stacked resilient member mid-sections isspread substantially across the end regions of the truss, as indicatedby directional arrows extending laterally from longitudinal centerlinea. FIG. 33 b particularly illustrates the preferred stepped fanfoldstacking order. Alternatively, FIG. 33 a illustrates the substantiallyrectangular resilient member positioned at the bottom of the stackingorder.

The end portions of the individual resilient members illustrated in FIG.34 have an identical, but reversed, curvature on either side of lateralcenterline b. Half of the resilient members are flipped laterally fromthe other half, preferably a pair of which are laterally andlongitudinally aligned with the truss. At least one additional pair ofresilient members are rotated slightly relative thereto. By virtue ofthe resilient member curvature, as well as being flipped laterally, andthe slight rotation of at least some of the resilient members, terminalends 23 thereof are progressively offset relative to longitudinalcenterline a, as indicated by broken lines in FIG. 34 a. This creates astepped reduction in thickness extending primarily laterally, at eachend regions, and very slightly arcuately, from longitudinal centerlinea.

This spatial arrangement of resilient members means that theirrespective mid-sections are not precisely overlaid, and the width of theresilient member structure thereat is not perfectly uniform. However,the cumulative resiliency of the stacked resilient member mid-sectionsis primarily imparted to the offset end portions and spread laterallyacross the end regions of the truss. To a lesser extent, the cumulativeresiliency generated at lateral centerline b is spread along thegradually increasing width of resilient member structure 22 extendinghorizontally outward from lateral centerline b to the opposite end edgesof the truss as indicated by directional arrows. FIG. 34 b moreparticularly illustrates the preferred stacking order of the constituentresilient members.

As illustrated and described in examples of the preferred embodiments,the present invention provides medical devices for dilating externaltissue, including a wide range of nasal dilator devices having complexresilient member structures, including methods of fabricating theconstituent members of said structures and corresponding finished nasaldilator devices.

I claim:
 1. a nasal dilator formed as a single body truss comprising: aresilient member structure extending from a first end region of thetruss through an intermediate region to a second end region of thetruss, the resilient member structure including at least two resilientmembers extending lengthwise along at least the intermediate region ofthe truss, at least a portion of an end edge of at least one resilientmember conforming with a portion of an end edge of the truss, theresilient members arranged in a spatial relationship such that at leasta portion of one flat surface side of at least one resilient memberoverlays at least a portion of one flat surface side of at least oneother resilient member.
 2. The nasal dilator of claim 1 wherein at leastone long edge of at least one resilient member intersects at least onelong edge of at least one other resilient member at an oblique anglethereto.
 3. The nasal dilator of claim 1 wherein: said at least oneresilient member has a first width and a first length; said at least oneother resilient member has a width exceeding the first width, and alength at least equal to the first length; and the flat surface side ofsaid at least one resilient member is overlaid entirely onto a portionof the width and at least a portion of the length of said at least oneother resilient member.
 4. The nasal dilator of claim 1 wherein: atleast one resilient member includes a substantially rectangularmid-section, at least one resilient member includes a substantiallyrectangular mid-section and divergent end portions; and said at least aportion of one flat surface side of at least one resilient member andsaid at least a portion of one flat surface side of at least one otherresilient member overlap along at least a portion of said substantiallyrectangular mid-sections.
 5. The nasal dilator of claim 1 wherein theresilient member structure includes discrete engagement contact points,at least two engagement contact points positioned at said first endregion and at least two engagement contact points positioned at saidsecond end region, the engagement contact points corresponding to springfinger components extending outward from a common center.
 6. The nasaldilator of claim 1 wherein at least one resilient member has at leastone material separation extending inward from at least one end edge, thematerial separation defining inside long edges of spring fingercomponents.
 7. The nasal dilator of claim 1 wherein the resilient memberstructure includes at least three overlaid resilient members ofprogressively decreasing width or length.
 8. The nasal dilator of claim1 wherein the resilient member structure comprises at least threeresilient members stacked at least substantially along mid-sectionsthereof.
 9. The nasal dilator of claim 1 wherein two resilient membersare vertically separated by an intermediate layer, the intermediatelayer dividing the resilient member structure into two or more resilientlayers.
 10. The nasal dilator of claim 1 wherein the resilient memberstructure forms the truss in its entirety.
 11. The nasal dilator ofclaim 1 and further including means for engaging the dilator to nasalouter wall tissues, said means secured to at least a portion of at leastone resilient member.
 12. The nasal dilator of claim 1 and furtherincluding an engagement element secured to at least a portion of atleast one resilient member, the engagement element comprising at leastone of a base layer, cover layer, or intermediate layer, the engagementelement defining at least a substantial portion of a periphery of thedilator.
 13. The nasal dilator of claim 12 wherein a peripheral outlineof the resilient member structure is contained wholly within aperipheral outline of the engagement element.
 14. A method offabricating a plurality of a resilient member structure, comprising thesteps of: a) forming a plurality of continuous slits in at least oneelongated web, the slits positioned across a width of the elongated web,the slits forming a plurality of adjacent elongated strands, the strandscomprising a plurality of interconnected resilient members; b)separating at least some of said elongated strands from the at least oneelongated webs into two or more groups; c) overlaying at least portionsof the elongated strands of at least one group onto at least portions ofthe elongated strands of at least one other group to form at least onecombined strand; and d) severing the at least one combined strandsacross a width thereof at prescribed locations along a length thereof soas to form a plurality of said resilient member structure.
 15. Themethod of claim 14 wherein: a) the elongated strands include portionsthat extend substantially parallel to a longitudinal centerline of theelongated web and portions that diverge from said longitudinalcenterline; b) said overlaying at least portions of the elongatedstrands of at least one group onto at least portions of the elongatedstrands of at least one other group overlays the strands in a continuouscrossing pattern; and c) said severing the combined strands forms theresilient member structure having non-overlap surface areas comprisingspring finger components extending outward from a common center definedby an overlap surface area.
 16. The method of claim 14 and furtherincluding: forming a fabrication laminate comprising at least oneadditional elongated material web; and cutting through the fabricationlaminate along prescribed lines corresponding to said prescribedlocations along a length of the combined strands, said cutting throughthe fabrication laminate forming at least a portion of a peripheraloutline of a plurality of a dilator device.
 17. A method of fabricatinga plurality of a resilient member structure, comprising the steps of: a)forming a plurality of continuous slits and enclosed die cut lines in atleast one elongated web, the web comprising a resilient material layerand an adhesive layer covered by a protective release liner, theenclosed die cut lines forming a plurality of spaced apart resilientmembers (b), the slits forming a plurality of adjacent elongatedstrands, the slits positioned laterally across a width of the elongatedweb, the strands comprising a plurality of interconnected resilientmembers (a); b) separating at least some of the elongated strands fromthe protective release liner so as to leave a plurality of resilientmembers (b) releasably secured thereon; c) overlaying one or more of theseparated strands onto at least some of the spaced apart resilientmembers (b) such that mid-sections of said interconnected resilientmembers (a) are substantially aligned to mid-sections of said spacedapart resilient members (b); and d) severing the strands across a widththereof at prescribed locations along a length thereof so as to form aplurality of said resilient member structure comprising resilientmembers (a) overlaid by resilient members (b).
 18. The method of claim17 wherein: a) said overlaying one or more of the separated strands ontoat least some of the spaced apart resilient members further includescombining the overlaid strands and spaced apart resilient members withat least one additional elongated material web so as to form afabrication laminate; and b) said severing the strands further includescutting through the fabrication laminate along prescribed lines to format least a portion of a peripheral outline of a plurality of a dilatordevice.
 19. The method of claim 17 wherein said separating at least someof the elongated strands from the protective release liner includesremoving resilient material from around and between said spaced apartresilient members (b) from said protective release liner, and layeringthe resilient material onto a separate protective release liner so as toform a second resilient material web, the continuous slits and elongatedstrands thus being formed therein, and the elongated strands thusseparated therefrom.
 20. The method of claim 19 and further including:a) forming enclosed die cut lines in the second resilient material web,the die cut lines positioned between the continuous slits so as to formadditional spaced apart resilient members, wherein the elongated strandsseparated therefrom leave the additional spaced apart resilient membersreleasably secured on said separate protective release liner; b)slitting the separate protective release liner so as to divide at leastsome of the additional spaced apart resilient members into elongatedstrips thereof; and c) overlaying at least two of the elongated stripsonto each other so as to align at least some of the additional resilientmembers from each strip to each other.
 21. The method of claim 20 andfurther including: a) combining the overlaid elongated strips with atleast one additional elongated material web so as to form a fabricationlaminate; and b) cutting through the fabrication laminate alongprescribed lines to form at least a portion of a peripheral outline of aplurality of a dilator device.